TITLE:
Evaluation of efficacy and safety of epalrestat and epalrestat in combination with methylcobalamin in patients with diabetic neuropathy in a randomized, comparative trial
AUTHORS:
Manish Maladkar, N. J. S. Saggu, P. Moralwar, Aziz A. Mhate, Datta Zemse, Anil Bhoraskar
KEYWORDS:
Epalrestat; Methylcobalamin; Diabetic Neuropathy
JOURNAL NAME:
Journal of Diabetes Mellitus,
Vol.3 No.1,
February
26,
2013
ABSTRACT: Recent Background: Diabetic neuropathy is one of the major complications in long standing hyperglycemic
patients. Though exact mechanism of neuronal damage is unclear, accumulation of
excess sorbitol through polyol pathway is believed to contribute significantly.
Epalrestat and methylcobalamin are extensively used in this area to counter
neuronal damage. This study was aimed to evaluate the combined effect of these
drugs. Materials and Methods: A total of 220 patients with diabetic
neuropathy were included in this study. The patients were divided into two
groups; group A was administered combination of epalrestat 50 mg and
methylcobalamin 500 mcg while group B was administered epalrestat 50 mg alone
(both thrice daily). The treatment period was 12 weeks with monitoring on week
4, 8 and 12 of the study. At baseline and at follow up visits following parameters
were evaluated: loss of sensation, burning sensation, numbness, muscle cramps,
spontaneous pain, weakness, dizziness, loss of the thermal sensitivity, tendon
reflexes, muscle strength and pain intensity using visual analog scale (VAS). Results: All the parameters were improved in both the groups compared to baseline. In
group A significant improvement was seen on week 4 itself and continued for the
rest of the study in all the measured parameters. Group B showed significant
improvement from 8th week onwards. The inter-group difference is statistically
significant in favour of the combination therapy. Conclusion: Combination of
epalrestat and methylcobalamin is a better option for the treatment of diabetic
neuropathy than epalrestat alone. Combination therapy was associated with
faster onset and better symptomatic relief.